Tenofovir Disoproxil Fumarate Approved in Europe for Treatment of Chronic Hepatitis B

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Title: Tenofovir Disoproxil Fumarate Approved in Europe for Treatment of Chronic Hepatitis B
URL: http://www.pslgroup.com/dg/220232.htm
Doctor's Guide
April 25, 2008

NEW YORK -- April 25, 2008 -- The European Commission has granted marketing authorisation for tenofovir disoproxil fumarate (Viread) for the treatment of chronic hepatitis B in all 27 member countries of the European Union.

Tenofir disoproxil fumarate is a once-daily tablet that blocks hepatitis B virus (HBV) DNA polymerase. Its approved use includes the treatment of adult patients who have HBV with compensated liver disease; with evidence of active viral replication; with persistently elevated serum alanine aminotransferase levels; and with histologic evidence of active inflammation, fibrosis, or both.

The approval was primarily based on data from 2 ongoing phase 3 clinical trials -- Studies 102 and 103 -- in patients chronically infected with HBV who were treatment-naive (n = 375). Some patients (n = 51) in the phase 3 trials had previous experience with lamivudine. The studies evaluated the effectiveness, safety, and tolerability of tenofovir disoprovil fumarate compared with adefovir dipivoxil (Hepsera).

Positive data from these studies were presented at the annual meeting of the American Association for the Study of Liver Diseases in Boston, Massachusetts, November 2007. Additional 72-week data from these studies were presented at the annual meeting of the European Association for the Study of the Liver in Milan, Italy, April 23 to 27, 2008.

"Hepatitis B is a significant problem in Europe, where approximately 20,000 people die of complications from the disease each year," said Patrick Marcellin, MD, PhD, Professor of Hepatology, University of Paris, Viral Hepatitis Research Unit, Hopital Beaujon, Clichy, France. "As a physician and researcher who has studied this drug extensively in large-scale clinical trials, I believe [tenofovir disoproxil fumarate] is an important treatment option for patients who are just starting therapy as well as for those who may have had previous experience with other medications, including lamivudine."

The most common adverse events among patients taking tenofovir disoproxil fumarate with other antiretroviral agents were mild to moderate gastrointestinal events and dizziness. Moderate to severe adverse events occurring in more than 5% of patients receiving the medication included rash, headache, pain, diarrhoea, depression, back pain, fever, nausea, abdominal pain, asthenia, and anxiety. In another study, less than 1% of patients discontinued participation because of gastrointestinal events.

Tenofovir disoproxil fumarate was recently approved for the treatment of chronic hepatitis B in Turkey and New Zealand, and marketing applications are currently pending regulatory review in the United States, Canada, and Australia. In the United States, the medication is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

SOURCE: Gilead Sciences, Inc.

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